(270 days)
The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment.
The YP-3000 has the functions of an infant incubator and an infant radiant warmer. The infant radiant warmer is optional, the two functions can be converted through the canopy lifting system. For the infant incubator, the temperature control system implements servo control on the temperature in the incubator (air temperature / skin temperature) and the device performs proportional heating control based on the setting of the temperature and the actual measured temperature. The internal air is adjusted through thermal convection to create an environment with proper temperature and humidity for infant incubation. It is intended to be used for constant temperature incubation of low birth weight infants, critically sick babies and neonates, as well as neonatal body temperature resuscitation, transfusion, oxygen therapy, emergency treatment, and hospitalization for neonates. The Infant radiant warmer transfers heat to the patient from the infrared radiation heating source through the parabolic reflecting hood transmitting heat to the patient on the mattress. proportional heating is controlled based on actual skin temperature. The device is equipped with a mattress, an electronic scale, and an oxygen control system. Other accessories include an observation lamp, tray, and an IV pole.
The provided text describes the 510(k) premarket notification for the YP-3000 Infant Incubator, demonstrating its substantial equivalence to a predicate device (OHMEDA MEDICAL OmniBed). This document focuses on proving equivalence through bench testing against recognized standards rather than detailing a clinical study with human readers or AI performance.
Therefore, many of the requested criteria for reporting an acceptance criteria and study proving performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable or not specified in this regulatory submission, as it is for a physical medical device (infant incubator/warmer) and not an AI/ML powered diagnostic device.
However, I can extract information related to the acceptance criteria for the device's technical specifications and how its performance was proven through non-clinical testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comprehensive comparison table between the subject device (YP-3000 Infant Incubator) and the predicate device (OmniBed), detailing various specifications and performance characteristics. The acceptance criteria essentially align with meeting the performance characteristics of the predicate device or demonstrating that any differences do not raise new questions of safety and effectiveness, often by showing compliance with relevant IEC and ISO standards.
| Acceptance Criteria (Corresponding Predicate Value or Standard) | Reported Device Performance (YP-3000) | Discussion of Equivalence and How Proven |
|---|---|---|
| Electrical Description | ||
| Power supply: 100V, 115V, 220V, 230V, 240V, 50/60Hz (Predicate) | AC 220-230V/50Hz; AC 110-120V/60Hz | Similar: Safety and performance tests based on IEC 60601-1, IEC 60601-2-19, and IEC 60601-2-21 cover both voltage ranges. Test results demonstrate compliance, raising no new safety/effectiveness questions. |
| Maximum current/power consumption: ≈1100VA (Predicate) | 1300VA | Similar: Safety and performance tests based on IEC 60601-1 conducted. Test results demonstrate compliance, raising no new safety/effectiveness questions. |
| Electrical safety: According to IEC 60601-1 (Predicate) | According to IEC 60601-1 | Same |
| Principles of Operation | ||
| General: Radiant Warmer and Infant Incubator (Predicate) | Radiant Warmer and Infant Incubator | Same |
| Control Modes: Incubator mode; Warmer mode (Predicate) | Incubator mode; Warmer mode | Same |
| Probe Type & Connectors: Air temp, Skin temp, air flow temp, O2, Humidity, Isolated air temp, Multi-port, RS232 (Predicate) | Air temp, Skin temp, air flow temp, O2, Humidity, Isolated air temp, Multi-port, RS232 | Same |
| Warmer Operation | ||
| Warmer: Radiant Warmer (Predicate) | Radiant Warmer | Same |
| Temperature Control Modes: Manual mode; Baby mode; (Pre-warm mode) (Predicate) | Pre-warm mode; Manual mode; Baby mode (Baby temperature control) | Same |
| Temperature Control Range Under Skin temp. Mode: 35~37.5°C in 0.1 increments (Predicate) | 34.5°C~37.5°C in 0.1 increments | Similar: Slightly wider range. Accuracy and consistency equivalent. Satisfies IEC60601-2-21 (201.15.4.2.2.101). No new safety/effectiveness questions. |
| Difference Between Skin Temperature Sensor and Control Temperature: ≤0.5°C (Predicate) | ≤0.5°C | Same |
| Temperature Uniformity of Bed Surface: ≤2°C (Predicate) | ≤2°C | Same |
| Incubator Operation | ||
| Heater: Convective heater (Predicate) | Convective heater | Same |
| Modes under the incubator mode: Air mode; Baby mode (Predicate) | Air mode; Baby mode | Same |
| Air Temperature Control range: 20~39℃ in 0.1 increments (Predicate) | 25~39℃ in 0.1 increments | Similar: Neonatal ambient temperature not less than 25℃, so YP-3000 range is designed accordingly. Accuracy and stability equivalent. Satisfies IEC60601-2-19 (201.15.4.2.2.101). No new safety/effectiveness questions. |
| Skin Temperature Control range: 35~37.5℃ in 0.1 increments (Predicate) | 34~38℃ in 0.1 increments | Similar: Slightly wider range. Accuracy and stability equivalent. Satisfies IEC60601-2-19 (201.15.4.2.2.102). No new safety/effectiveness questions. |
| Temperature Rise Time: 85% (Predicate) | ±5% RH | Similar: Better precision for YP-3000. No new safety/effectiveness questions. |
| Oxygen Concentration Control Range: 21% O₂~65% O₂ (Predicate) | 20% O₂~60% O₂ | Similar: YP-3000 range is included in predicate's range and verified to meet design requirement. No new safety/effectiveness questions. |
| Oxygen Concentration Control Precision: ±5% O₂ (Predicate) | ±4% O₂ | Similar: Slightly different but verified to meet design requirement. No new safety/effectiveness questions. |
| Carbon dioxide (CO2) Concentration Inside the Hood Under Incubator Mode: 0.2% (Predicate) | 38°C (SET≤37°C), >40°C (SET>37°C) (Predicate) | Temperature of incubator is not over 38°C (set value is less than 37°C), or not over 39.5°C (set value is over than 37°C) |
| Skin Overheat Alarm: Not provided (Predicate) | The temperature measured by skin temperature sensor under the warmer mode is over 38.5°C | Similar: Both meet IEC 60601-2-19 (201.15.4.2.1 bb). No new safety/effectiveness questions. |
| Water Shortage: Water tank is lacking water (Predicate) | Water tank is lacking water | Same |
| Operating Condition Description | ||
| Temperature: +20~+30°C (Predicate) | +20~+30°C | Same |
| Humidity: 10% to 95% RH (Predicate) | 30%~75%RH | Similar: Environmental test report proves YP-3000 works normally under this condition. No new safety/effectiveness questions. |
| Storage Condition Description | ||
| Temperature: -25~+60°C (Predicate) | -20~+55°C | Similar: Environmental testing supports performance as intended. No new safety/effectiveness questions. |
| Relative humidity: ≤95%RH (Predicate) | ≤93%RH | Similar: Environmental testing supports performance as intended. No new safety/effectiveness questions. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This is a physical medical device. Performance claimed is based on laboratory bench testing against recognized standards, not on a data set of patient cases.
- Data Provenance: Not applicable. The "data" here refers to the outcomes of physical device measurements and assessments in a laboratory setting. No geographical or retrospective/prospective data collection is relevant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a physical device's performance (e.g., temperature accuracy, noise levels) is established through standardized engineering and safety tests, not through expert human interpretation of medical data (like in AI diagnostics). The "experts" involve engineers and technicians conducting the tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human or AI interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This is a medical device for infant care, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm. Bench testing demonstrates its standalone performance (i.e., the device itself performs according to specifications).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: The "ground truth" for this device's performance is derived from measurements taken during rigorous bench testing against established international performance and safety standards (e.g., IEC 60601 series, ISO 10993 series). These standards define acceptable ranges for various parameters (temperature control, humidity, noise, alarms, electrical safety, biocompatibility, etc.). The device's measurements serve as its performance, and these are compared against the required thresholds and the predicate device's performance.
8. The sample size for the training set:
- Not applicable. This device does not use a training set as it is not an AI/ML system.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for this physical device.
§ 880.5400 Neonatal incubator.
(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).